Pain Relief Results After Anterior Cruciate Ligament (ACL) Reconstruction - Full Text View

Sponsors and Collaborators:	National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS) University of Pittsburgh
Information provided by:	National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS)
ClinicalTrials.gov Identifier:	NCT00022854

Purpose

Anterior cruciate ligament (ACL) reconstruction is surgery that is done to repair a damaged ligament in the knee. In this study we will look at whether the femoral nerve block, a commonly used method for pain relief after ACL reconstruction, affects the way patients feel after surgery. We will study recovery during the first week after surgery and also 3-12 weeks after surgery. We will give all patients spinal anesthesia. Some patients will also receive a continuous femoral nerve block for 2 days, or by a single injection. We predict that patients who received the nerve block will have significantly improved pain results, compared to patients who did not receive the nerve block.

Condition	Intervention	Phase
Anterior Cruciate Ligament Rupture	Procedure: Single-injection femoral nerve block Procedure: Femoral nerve block 60-hour continuous injection Procedure: Saline (control) injection into femoral nerve envelope	Phase IV

MedlinePlus related topics: Anesthesia Nausea and Vomiting Surgery

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Randomized, Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Placebo Control, Parallel Assignment, Efficacy Study
Official Title:	Outcomes After ACL Reconstruction: The Effect of Femoral Nerve Block Analgesia

Further study details as provided by National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS):

Primary Outcome Measures:

Pain scores during the first week after surgery [ Time Frame: one week ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

Side effects during the first week after surgery (nausea, vomiting, quality of sleep) [ Time Frame: first week after surgery ] [ Designated as safety issue: No ]
Determine the "rebound pain score" after a nerve block wears off [ Time Frame: first week after surgery ] [ Designated as safety issue: No ]
Skin reactions to the nerve block catehter dressing [ Time Frame: first week after surgery ] [ Designated as safety issue: Yes ]
Risk of falling [ Time Frame: first week after surgery ] [ Designated as safety issue: Yes ]
Validation of an 8-item outcome survey in comparison to a 40-item "gold standard" outcome survey [ Time Frame: first week after surgery ] [ Designated as safety issue: No ]
Study staffing costs before and after the implementation of HIPAA [ Time Frame: the 40 months of study recruitment ] [ Designated as safety issue: No ]
Patient-reported general health status, and patient-reported knee function, during the first 12 weeks after surgery [ Time Frame: up to 12 weeks after surgery ] [ Designated as safety issue: No ]

Enrollment:	270
Study Start Date:	May 2001
Study Completion Date:	January 2005

Arms	Assigned Interventions
1: Placebo Comparator	Procedure: Saline (control) injection into femoral nerve envelope Nerve block bolus with 30 mL saline, followed by continuous saline infusion
2: Experimental Nerve block bolus with 30 mL levobupivacaine 0.25%, followed by continuous saline infusion	Procedure: Single-injection femoral nerve block Nerve block bolus with 30 mL levobupivacaine 0.25%, followed by continuous saline infusion
3: Experimental Nerve block bolus with 30 mL levobupivacaine 0.25%, followed by continuous levobupivacaine infusion of 5 mL/hr for 50 hr	Procedure: Femoral nerve block 60-hour continuous injection Nerve block bolus with 30 mL levobupivacaine 0.25%, followed by continuous infusion (5 mL/hr for 50 hours) of 0.25% levobupivacaine

Detailed Description:

In this project, we will measure outcomes of anesthesia and pain management for common orthopedic procedures. The influence of nerve block pain management on outcomes after outpatient anterior cruciate ligament (ACL) reconstruction has not been studied, especially the patient's potential to return to societal productivity during the first week after surgery. Therefore, we have designed a randomized clinical trial to study the role of nerve block pain management techniques on patient outcomes during the first week after surgery and on recovery 3-12 weeks after surgery. Our hypothesis is that patients undergoing nerve block analgesia will manifest better self-reported recovery outcomes, physical function outcomes, and objective measures of neuromuscular function.

We will give consenting patients (n=270) undergoing ACL reconstruction conventional spinal anesthesia and will randomize them to receive femoral nerve block analgesia with either a single injection, a continuous infusion for 2 days, or saline placebo. We will use goniometry to test postoperative range of motion in extension to determine whether the quadriceps femoris torque output is impaired. We will compare patient-reported recovery outcomes across treatment groups using three validated health status measures suitable for daily assessment (Verbal Pain Score, SF-8, and the Quality of Recovery [from anesthesia, QoR-40] Score).

We aim to determine the quality of immediate recovery from anesthesia and the extent of reported pain. We will compare the effects of single injection and continuous infusion on femoral nerve analgesia to determine the better dosing strategy for these patients.

Eligibility

Ages Eligible for Study:	14 Years to 65 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

Inclusion Criteria:

Age 14-65
Undergoing ACL reconstruction at the University of Pittsburgh
Agrees to spinal anesthesia and consents to one of the three nerve block interventions.
Agrees to visit the University of Pittsburgh Center for Rehabilitation Services for postoperative physical therapy and rehabilitation (for standardized rehabilitation protocols)

Exclusion Criteria:

Morbid obesity
Chronic pain syndromes
Opioid dependence
Corticosteroid prescriptions
Tricyclic antidepressant prescriptions
Tramadol prescriptions
Preexisting neuropathies
Poorly controlled diabetes mellitus
Poorly controlled anxiety disorders

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00022854

Locations

United States, Pennsylvania
University of Pittsburgh Medical Center, Center for Sports Medicine
Pittsburgh, Pennsylvania, United States, 15203

Sponsors and Collaborators

National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS)

University of Pittsburgh

Investigators

Principal Investigator:

Brian A. Williams, MD, MBA

University of Pittsburgh

More Information

Publications:

Williams BA, Kentor ML, Vogt MT, Irrgang JJ, Bottegal MT, West RV, Harner CD, Fu FH, Williams JP. Reduction of verbal pain scores after anterior cruciate ligament reconstruction with 2-day continuous femoral nerve block: a randomized clinical trial. Anesthesiology. 2006 Feb;104(2):315-27.

Williams BA, Kentor ML, Irrgang JJ, Bottegal MT, Williams JP. Nausea, vomiting, sleep, and restfulness upon discharge home after outpatient anterior cruciate ligament reconstruction with regional anesthesia and multimodal analgesia/antiemesis. Reg Anesth Pain Med. 2007 May-Jun;32(3):193-202.

Williams BA, Bottegal MT, Kentor ML, Irrgang JJ, Williams JP. Rebound pain scores as a function of femoral nerve block duration after anterior cruciate ligament reconstruction: retrospective analysis of a prospective, randomized clinical trial. Reg Anesth Pain Med. 2007 May-Jun;32(3):186-92.

Bost JE, Williams BA, Bottegal MT, Dang Q, Rubio DM. The 8-item Short-Form Health Survey and the physical comfort composite score of the quality of recovery 40-item scale provide the most responsive assessments of pain, physical function, and mental function during the first 4 days after ambulatory knee surgery with regional anesthesia. Anesth Analg. 2007 Dec;105(6):1693-700, table of contents.

Williams BA, Kentor ML, Bottegal MT. The incidence of falls at home in patients with perineural femoral catheters: a retrospective summary of a randomized clinical trial. Anesth Analg. 2007 Apr;104(4):1002. No abstract available.

Williams BA, Bolland MA, Orebaugh SL, Bottegal MT, Kentor ML. Skin reactions at the femoral perineural catheter insertion site: retrospective summary of a randomized clinical trial. Anesth Analg. 2007 May;104(5):1309-10. No abstract available.

Williams BA, Bottegal MT, Francis KA, Irrgang JJ, Vogt MT. A post hoc analysis of research study staffing: budgetary effects of the Health Insurance Portability and Accountability Act on research staff work hours during a prospective, randomized clinical trial. Anesthesiology. 2007 Nov;107(5):860-1. No abstract available.

Williams BA, Kentor ML, Williams JP, Figallo CM, Sigl JC, Anders JW, Bear TC, Tullock WC, Bennett CH, Harner CD, Fu FH. Process analysis in outpatient knee surgery: effects of regional and general anesthesia on anesthesia-controlled time. Anesthesiology. 2000 Aug;93(2):529-38.

Williams BA, Kentor ML, Williams JP, Vogt MT, DaPos SV, Harner CD, Fu FH. PACU bypass after outpatient knee surgery is associated with fewer unplanned hospital admissions but more phase II nursing interventions. Anesthesiology. 2002 Oct;97(4):981-8.

Williams BA, Kentor ML, Vogt MT, Williams JP, Chelly JE, Valalik S, Harner CD, Fu FH. Femoral-sciatic nerve blocks for complex outpatient knee surgery are associated with less postoperative pain before same-day discharge: a review of 1,200 consecutive cases from the period 1996-1999. Anesthesiology. 2003 May;98(5):1206-13.

Williams BA, Kentor ML, Vogt MT, Vogt WB, Coley KC, Williams JP, Roberts MS, Chelly JE, Harner CD, Fu FH. Economics of nerve block pain management after anterior cruciate ligament reconstruction: potential hospital cost savings via associated postanesthesia care unit bypass and same-day discharge. Anesthesiology. 2004 Mar;100(3):697-706.

Responsible Party:	University of PIttsburgh ( Allen DiPalma, Director - Office of Research )
Study ID Numbers:	K23 AR47631, NIAMS-066
Study First Received:	August 14, 2001
Last Updated:	December 14, 2007
ClinicalTrials.gov Identifier:	NCT00022854 History of Changes
Health Authority:	United States: Federal Government

Keywords provided by National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS):

ACL
Nerve block
Knee
Outcome survey

Anesthesia
Analgesia
Pain

Study placed in the following topic categories:

Levobupivacaine
Anesthetics
Rupture
Pain

ClinicalTrials.gov processed this record on May 06, 2009